Cleviprex 0,5 mg/ml, emulsie voor injectie

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:
1. What Cleviprex is and what it is used for
2. What you need to know before you are given Cleviprex
3. How Cleviprex is used
4. Possible side effects
5. How to store Cleviprex
6. Contents of the pack and other information

1. What Cleviprex is and what it is used for Cleviprex contains the active substance clevidipine.

Clevidipine is a calcium channel blocker. Calcium channel blockers are medicines which lower blood pressure.

Cleviprex is used to lower blood pressure in adult patients preparing for surgery, undergoing surgery or immediately after surgery.

2. What you need to know before you are given Cleviprex
Do not use Cleviprex:
- if you are allergic (hypersensitive) to clevidipine, soybeans, soya-bean oil, soy products, peanut, eggs or egg products or to any of the other ingredients of Cleviprex
- if you have a condition where you have extremely high levels of fat in your blood including acute inflammation of the pancreas or kidney problems
- if you have a kidney disorder that causes loss of protein in urine
Check with your doctor if you are unsure.

Warnings and precautions
Talk to your doctor before using Cleviprex:
- if you have a heart condition where the aortic valve in your heart does not open completely
- if you have an abnormally large heart caused by narrow blood vessels (hypertrophic obstructive cardiomyopathy)
- if you have a heart condition where a valve is narrowed (stenosis of the mitral valve)
- if you have a tear in the main artery of the body (aortic dissection)
- if you have a tumour of the gland on top of the kidney (adrenal gland) that causes high blood pressure (pheochromocytoma)
- if you have had a heart attack
- if you have a condition where your heart cannot increase in rate in order to compensate for reduced blood pressure such as
* an electrical problem with your heart
* you are fitted with a pacemaker

Other medicines and Cleviprex
Please tell your doctor if you are taking, have recently taken or might take any other medicines.

It is particularly important that you tell your doctor if you have been taking any medicines to lower your blood pressure.

Pregnancy and breast-feeding
You must tell the doctor if:
- you are pregnant or think you may be pregnant - you are planning on becoming pregnant
- you are breast-feeding
There is no adequate information on the use of Cleviprex in pregnant women. Cleviprex should not be used during pregnancy unless clearly necessary. Your doctor will decide whether or not this treatment is appropriate for you.
It is not known whether Cleviprex is excreted in breast-milk. If you are breast-feeding, the doctor will decide whether Cleviprex should be used.

Driving and using machines

Cleviprex is used to lower your blood pressure, which may make you feel light-headed or dizzy and could affect your ability to drive or use machines.
You must not drive or operate machinery until the effects of Cleviprex have worn off. Check with your doctor before leaving hospital if you are unsure.

Cleviprex contains soya oil
If you are allergic to peanut or soya, do not use this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.

3. How Cleviprex is used Cleviprex is for infusion (drip) into a vein. This is administered by a doctor.
Your treatment with Cleviprex will be supervised by a doctor as Cleviprex is administered in the hospital. The doctor will decide how much Cleviprex you receive and will prepare the medicine.
- Throughout your treatment, the doctor will check your blood pressure
- Before the start of infusion the doctor will tell you about the signs of allergic reaction
- The dose and duration of infusion depends upon the kind of treatment you are undergoing Dosage

An infusion of Cleviprex should be started at 4 ml/hour (2 mg/hour) and increased as tolerated in doubling amounts (i.e. 4 to 8, 8 to 16, 16 to 32, 32 to 64 ml/hour [2 to 4, 4 to 8, 8 to 16, 16 to
32 mg/hour]) every 90 seconds.

Cleviprex will reduce blood pressure for most patients at doses up to 32 ml/hour (16 mg/hour). Some patients may require a dose up to 64 ml/hour (32 mg/hour).

If you have more Cleviprex than you should

These doses are carefully checked by the doctor, so an overdose is very unlikely. In the event of taking too much Cleviprex, the infusion will be reduced or stopped.
If you are concerned that you may have been given too much Cleviprex, talk to your doctor or other medical staff immediately.

If you forget to have Cleviprex
Since treatment with Cleviprex is administered and supervised by a doctor, this is very unlikely. If you are concerned that you may have missed a dose, talk to your doctor immediately.

While you are receiving Cleviprex
If you develop severe allergic reactions, like swelling of your face and/or throat or fever tell your doctor immediately.

If you have further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild and do not last very long.

Very common: may affect more than 1 in 10 people - headache
- atrial fibrillation (irregular heart beat)
- tachycardia (fast heart beat)
- hypotension (low blood pressure)

Common: may affect up to 1 in 10 people
- dizziness
- nausea
- polyuria (producing large volumes of urine)
- oedema (swelling) at the injection site
- flushing (reddening of the skin)
- feeling hot
- itching
- chest discomfort or pain
- allergic reaction
- vomiting

Uncommon: may affect up to 1 in 100 people
- atrial flutter (abnormal heart rhythm)
- hypoxia (lower blood oxygen levels)
- heart failure
- slow heart beat
- atrioventricular block (feeling your heart beat)
- constipation
- hyperlipidaemia (high fat levels in the blood)
- lung congestion

Rare: may affect up to 1 in 1000 people
- ileus (constipation; obstruction of the digestive system [bowel])
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

5. How to store Cleviprex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date refers to the last day of that month.
Store and transport refrigerated (2°C – 8°C). Do not freeze
May be stored below 25°C for a period not to exceed 2 months. Do not return to refrigerated storage after beginning 25°C storage. Once the container is opened, any remaining product should be discarded after 12 hours.
Keep vial in the outer carton in order to protect from light
The emulsion should be milky white.
The doctor will check the emulsion and will discard it if it contains particles or is discoloured.
Do not throw away medicines via wastewater or household waste. The healthcare professional administering Cleviprex will be responsible for ensuring that any unused product or waste material is disposed of in accordance with local requirements. These measures will help protect the environment.

6. Contents of the pack and other information

What Cleviprex contains

- The active substance is clevidipine
1 ml emulsion for injection contains 0.5 mg clevidipine. One vial of 50 ml of emulsion contains 25 mg of clevidipine
One vial of 100 ml of emulsion contains 50 mg of clevidipine

- The other ingredients are soya-bean oil refined, glycerol, purified egg yolk phospholipids and sodium hydroxide (for pH adjustment)

What Cleviprex looks like and contents of the pack

Cleviprex is a milky white emulsion in a glass vial
Cleviprex is available in cartons containing 10 vials of 50 ml and 10 vials of 100 ml. Not all vial sizes may be marketed.

Marketing Authorisation Holder
The Medicines Company UK Ltd.
1 15L Milton Park
OX14 4SA
Verenigd Koninkrijk

Hälsa Pharma GmbH
Nikolaus-Dürkopp-Str. 4A,
D-33602 Bielefeld,

Dit geneesmiddel is geregistreerd onder:
Cleviprex 0,5 mg/ml, emulsie voor injectie RVG 104771

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Cleviprex 0,5 mg/ml emulsion zur injektion
Belgium: Cleviprex 0,5 mg/ml émulsion injectable;
Cleviprex 0,5 mg/ml, emulsie voor injectie;
Cleviprex 0,5 mg/ml emulsion zur injektion
France: Cleviprex 0,5 mg/ml émulsion injectable
Germany: Cleviprex 0,5 mg/ml emulsion zur injektion
Italy: Cleviprex 0,5 mg/ml emulsione iniettabile
Luxembourg: Cleviprex 0,5 mg/ml émulsion injectable
Netherlands: Cleviprex 0,5 mg/ml, emulsie voor injectie
Spain: Cleviprex 0,5 mg/ml emulsión para inyección
Sweden: Cleviprex 0,5 mg/ml injektionsvätska, emulsion
UK: Cleviprex 0.5 mg/ml emulsion for injection

This leaflet was last revised in november 2011